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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05865834
Other study ID # 8053
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date November 15, 2023

Study information

Verified date May 2023
Source Aga Khan University
Contact Shafquat Rozi, Ph.D.
Phone +92 300 2278976
Email shafquat.rozi@aku.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the goal of this cluster randomized controlled trial is to assess the effectiveness of smartphone application in reducing the symptoms of Anxiety and depression among adolescents. The main objectives of this trial are: 1. Primary Objective To develop a smart phone application for reduction in depressive and anxiety symptoms in Pakistani adolescents aged 12-18 years 2. Secondary Objectives - To determine the effectiveness of a smart phone application in reduction of anxiety symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial - To determine the effectiveness of a smart phone application in reduction of depressive symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial - To determine the effectiveness of a smart phone application in improvements of well-being of Pakistani adolescents aged 12-18 years via a randomized controlled trial the randomization will occur at the school level for the intervention group and control group. Students in the intervention group will receive the access to a smartphone application designed to improve the mental health of adolescents, they will be briefed on how to use the application and its advantages. while the students in the control group will receive self-reading pictorial educational leaflets related to mental health improvement. the researcher will conduct the assessment of depression, anxiety and mental wellbeing using PHQ-A, GAD-7 and WHO-5 at baseline, 1 month and at 3 months to compare if the smartphone application is effective in reducing the symptoms of depression and anxiety of adolescents and overall improvement in the mental wellbeing.


Description:

As per World Health Organization (WHO), 13% of adolescents worldwide experience a mental disorder. Also, depression, anxiety, and other behavioral disorders are leading causes of mortality and disability in this age bracket. The advent of the pandemic has further worsened the mental health situation in adolescents. If the increasing burden of mental health issues is not addressed in adolescence, they can culminate into established mental disorders extending to adulthood, impairing overall wellbeing and limiting opportunities. In order to cater to mental health issues in adolescents at an early stage, we aim to develop a smartphone application for the reduction of depression and anxiety symptoms in school-going adolescents aged 12-18 years. Also, we plan to assess the effectiveness of the smartphone application via a cluster randomized controlled trial. The curated smartphone application will have two modules: Chill zone and sleep; Chill zone will comprise of 9 sub-modules and sleep 5 sub-modules. The 9 sub-modules of the Chill zone will be as follows; meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini-courses, and how to become better. The sub-modules of sleep will be winding down, sleep music, storytelling, nature sounds, and beautiful nature. Each module will be designed to be completed on separate days with daily push notifications. Once the application is designed, the trial will be conducted in schools of Karachi. The intervention and control arm will have two schools with 50 students/school from grades 6-10. The total sample size will be 200 students. A two-stage cluster sampling with stratification on school type (government or private) will be employed to select schools and recruit students. Participants allocated to the intervention arm will be given mental health intervention, and the students in the control arm will be given educational leaflets. PHQ-A, GAD-7, and WHO depression wellbeing scale for assessing depressive symptoms, anxiety symptoms, and wellbeing will be used at baseline, 1 month, and three months. Generalized estimating equation, will be used to compare mean scores of depression, anxiety and wellbeing scores between both arms.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date November 15, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Registered secondary schools with the Board of Secondary Education Karachi who will provide consent to participate in the study - 12-18-year-olds adolescents enrolled in public and private school of Karachi Pakistani - The intervention and control arm must understand English or Urdu in order to use the mobile-based application. - Intervention group must have access to a smartphone or portable smart device (Electronic Tablets, iPad, etc.). - Participants having access to Wi-Fi at home- or on the phone for downloading the app. - Parenteral consent is required for an adolescent to participate in this study; simultaneously, an individual's consent is equally important to be included in this trial. - Moreover, students will be asked to participate in the study if they:(a) experience mild to moderate depression defined as scoring above the cut-off score of 4 on the Patient Health Questionnaire for adolescents (PHQ-A) and/or anxiety symptoms defined as scoring above the cut-off score of 5 on the Generalized Anxiety Disorder scale-7 items (GAD-7 (b) had a well-being score of =50 on World Health Organization Well-Being scale (WHO-5) at basic screening level. Exclusion Criteria: - School authorities who did not grant permission to conduct the research study in their school - School unable or unwilling to provide informed consent /assent - students not willing to participate in the study - Use of a mobile device that does not comply with the app requirements (non- android phone holders) - Have no internet access or smartphone - Students will be excluded if they: (a) any chronic disease (c) currently taking psychiatric consultation/ treatment for depression/ anxiety, or have received treatment/therapy in the past 12 months

Study Design


Intervention

Other:
A smartphone application
app will have 2 modules: Chill zone and sleep; Chill zone has 9 sub-modules which are meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini courses and how to become better. The sub-modules of sleep are: wind down, sleep music, storytelling, nature sounds and beautiful nature. These modules will be approved by a clinical psychologist to help people with symptoms of depression and anxiety. Skills learned include emotion recognition, emotional management, behavioral activation (being active), recognizing and challenging unhelpful thoughts and cognitive restructuring to plan for their future.
Pictorial educational leaflets
the control group will receive self-reading educational leaflets, the majority of which are pictorial. These leaflets will be approved by a clinical psychologist to help people with symptoms of depression and anxiety.

Locations

Country Name City State
Pakistan Aga Khan University- Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (17)

Balaji M, Andrews T, Andrew G, Patel V. The acceptability, feasibility, and effectiveness of a population-based intervention to promote youth health: an exploratory study in Goa, India. J Adolesc Health. 2011 May;48(5):453-60. doi: 10.1016/j.jadohealth.2010.07.029. Epub 2010 Oct 2. — View Citation

Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available. — View Citation

Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28. — View Citation

de Bruin EJ, Bogels SM, Oort FJ, Meijer AM. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition. Sleep. 2015 Dec 1;38(12):1913-26. doi: 10.5665/sleep.5240. — View Citation

Gao Y, Li LP, Kim JH, Congdon N, Lau J, Griffiths S. The impact of parental migration on health status and health behaviours among left behind adolescent school children in China. BMC Public Health. 2010 Feb 3;10:56. doi: 10.1186/1471-2458-10-56. — View Citation

Grist R, Porter J, Stallard P. Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. J Med Internet Res. 2017 May 25;19(5):e176. doi: 10.2196/jmir.7332. — View Citation

Ha T, van Roekel E, Iida M, Kornienko O, Engels RCME, Kuntsche E. Depressive Symptoms Amplify Emotional Reactivity to Daily Perceptions of Peer Rejection in Adolescence. J Youth Adolesc. 2019 Nov;48(11):2152-2164. doi: 10.1007/s10964-019-01146-4. Epub 2019 Oct 16. — View Citation

Hellfeldt K, Lopez-Romero L, Andershed H. Cyberbullying and Psychological Well-being in Young Adolescence: The Potential Protective Mediation Effects of Social Support from Family, Friends, and Teachers. Int J Environ Res Public Health. 2019 Dec 19;17(1):45. doi: 10.3390/ijerph17010045. — View Citation

Karyotaki E, Klein AM, Riper H, Wit L, Krijnen L, Bol E, Bolinski F, Burger S, Ebert DD, Auerbach RP, Kessler RC, Bruffaerts R, Batelaan N, van der Heijde CM, Vonk P, Kleiboer A, Wiers RW, Cuijpers P. Examining the effectiveness of a web-based intervention for symptoms of depression and anxiety in college students: study protocol of a randomised controlled trial. BMJ Open. 2019 May 14;9(5):e028739. doi: 10.1136/bmjopen-2018-028739. — View Citation

Khalid A, Qadir F, Chan SWY, Schwannauer M. Adolescents' mental health and well-being in developing countries: a cross-sectional survey from Pakistan. J Ment Health. 2019 Aug;28(4):389-396. doi: 10.1080/09638237.2018.1521919. Epub 2018 Nov 19. — View Citation

Mason-Jones AJ, Crisp C, Momberg M, Koech J, De Koker P, Mathews C. A systematic review of the role of school-based healthcare in adolescent sexual, reproductive, and mental health. Syst Rev. 2012 Oct 26;1:49. doi: 10.1186/2046-4053-1-49. — View Citation

Moore SE, Norman RE, Suetani S, Thomas HJ, Sly PD, Scott JG. Consequences of bullying victimization in childhood and adolescence: A systematic review and meta-analysis. World J Psychiatry. 2017 Mar 22;7(1):60-76. doi: 10.5498/wjp.v7.i1.60. eCollection 2017 Mar 22. — View Citation

Rao S, Shah N, Jawed N, Inam S, Shafique K. Nutritional and lifestyle risk behaviors and their association with mental health and violence among Pakistani adolescents: results from the National Survey of 4583 individuals. BMC Public Health. 2015 Apr 28;15:431. doi: 10.1186/s12889-015-1762-x. — View Citation

Razzak HA, Harbi A, Ahli S. Depression: Prevalence and Associated Risk Factors in the United Arab Emirates. Oman Med J. 2019 Jul;34(4):274-282. doi: 10.5001/omj.2019.56. — View Citation

Salam RA, Das JK, Lassi ZS, Bhutta ZA. Adolescent Health and Well-Being: Background and Methodology for Review of Potential Interventions. J Adolesc Health. 2016 Oct;59(4S):S4-S10. doi: 10.1016/j.jadohealth.2016.07.023. — View Citation

van Dalen M, Dierckx B, Pasmans SGMA, Aendekerk EWC, Mathijssen IMJ, Koudstaal MJ, Timman R, Williamson H, Hillegers MHJ, Utens EMWJ, Okkerse JME. Anxiety and depression in adolescents with a visible difference: A systematic review and meta-analysis. Body Image. 2020 Jun;33:38-46. doi: 10.1016/j.bodyim.2020.02.006. Epub 2020 Feb 21. — View Citation

Zisk A, Abbott CH, Bounoua N, Diamond GS, Kobak R. Parent-teen communication predicts treatment benefit for depressed and suicidal adolescents. J Consult Clin Psychol. 2019 Dec;87(12):1137-1148. doi: 10.1037/ccp0000457. Epub 2019 Oct 24. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety change in the level of anxiety symptoms using the Generalized anxiety scale (GAD-7) 6 months
Primary Depression Change in the level of depressive symptoms assessed using Patient Health Questionnaire (PHQ-A) adapted for adolescents 6 months
Primary Mental well-being change in the mental well-being scores assessed using WHO-5 scale 6 months
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